LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial.

BACKGROUND: Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS: In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS: Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. FUNDING: Meril Life Sciences.

ACEF performed better than other risk scores in non-ST-elevation acute coronary syndrome during long term follow-up.

BACKGROUND: Risk stratification of patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) is an important clinical method, but long-term studies on patients subjected to all-treatment strategies are lacking. Therefore, the aim was to compare several established risk scores in the all-treatment NSTE-ACS cohort during long-term follow-up. METHODS: Consecutive patients (n = 276) with NSTE-ACS undergoing coronary angiography were recruited between September 2012 and May 2015. Six risk scores for all patients were calculated, namely GRACE 2.0, ACEF, SYNTAX, Clinical SYNTAX, SYNTAX II PCI and SYNTAX II CABG. The primary end-point was Major Adverse Cardiovascular Events (MACE) which was a composite of cardiac death, nonfatal myocardial infarction, ischemic stroke or urgent coronary revascularization. RESULTS: During a median follow-up of 33 months, 64 MACE outcomes were recorded (23.2%). There was no difference between risk score categories, except in the highest risk group of ACEF and SYNTAX II PCI scores which exhibited significantly more MACE (51.6%, N = 33 and 45.3%, N = 29, P = 0.024, respectively). In the multivariate Cox regression analysis of individual variables, only age and atrial fibrillation were significant predictors for MACE (HR 1.03, 95% CI 1.00-1.05, P = 0.023 and HR 2.02, 95% CI 1.04-3.89, P = 0.037, respectively). Furthermore, multivariate analysis of the risk scores showed significant prediction of MACE only with ACEF score (HR 2.16, 95% CI 1.36-3.44, P = 0.001). The overall performance of GRACE, SYNTAX, Clinical SYNTAX and SYNTAX II CABG was poor with AUC values of 0.596, 0.507, 0.530 and 0.582, respectively, while ACEF and SYNTAX II PCI showed the best absolute AUC values for MACE (0.630 and 0.626, respectively). CONCLUSIONS: ACEF risk score showed better discrimination than other risk scores in NSTE-ACS patients undergoing all-treatment strategies over long-term follow-up and it could represent a fast and user-friendly tool to stratify NSTE-ACS patients.

Coronavirus epidemic in Croatia: case fatality decline during summer?

AIM: To describe the SARS-CoV-2 epidemic pattern in Croatia during February-September 2020 and compare the case fatality ratio (CFR) between spring and summer. METHODS: National data were used to calculate the weekly and monthly CFRs, stratified by three age groups: 0-64, 65-79, and 80+ years. We also calculated the standardized mortality ratios (SMR) to offset the differences in age composition. RESULTS: The epidemic consisted of the initial wave, a trough in June, and two conjoined summer waves, yielding 17206 coronavirus disease 2019 cases and 290 deaths. While the number of confirmed cases nearly quadrupled during summer, case fatality estimates decreased; CFR in spring was 4.81 (95% confidence interval 3.91-5.71), compared with 1.24 (1.06-1.42) in summer. The SMR for summer was 0.45 (0.37-0.55), suggesting that the case fatality risk halved compared with spring. Cardiovascular comorbidity was an important risk factor for case fatality (SMR 2.63 [2.20-3.13] during spring and 1.28 [1.02-1.59] during summer). The risk of death in ventilated patients remained unchanged (SMR 0.98 [0.77-1.24]). CONCLUSIONS: The epidemic dynamics suggests summer decline in case fatality, except in ventilated patients. While the effect of comorbidity also decreased, cardiovascular comorbidity remained an important risk factor for death even during summer. A plethora of possible confounders and an ever-changing landscape of SARS-CoV-2 epidemic in Croatia require constant monitoring and evaluation, with an aim to prevent the uncontrolled spread of the virus and a disruption of health care functioning.

[Primary percutaneous coronary intervention (pPCI) in hospital without regional cardiac surgery support, data from Split region]. / Primarna perkutana koronarna intervencija (pPCI) bez kardiokirurske potpore u regiji; iskustvo iz Splita.

OBJECTIVES: The aim of our study was to investigate the feasibility of pPCI in hospital without cardiac surgery, and to compare our "real-world" results to current guidelines and historical controls. METHODS: Data of all STEMI patients treated by PCI were prospectively recorded. RESULTS: From January 2005 through October 2007, 366 consecutive patients with STEMI were enrolled. In-hospital mortality was 6.3%, as compared to 15% (87/543) in historical records of a three year period before pPCI program was developed. Pain to balloon time was 315 minutes, pain to first medical contact was 102 minutes, first medical contact to door was 94 minutes, door to cathlab time was 84 minutes, cathlab to balloon time was 45 minutes, and door to balloon time was 129 minutes. CONCLUSIONS: Our preliminary experience indicates that implementation of pPCI in a hospital without regional cardiac surgical back-up is feasible and offers significant mortality reduction in STEMI patients. Intrahospital time delays should be managed aggressively.

[Cardiac valves calcifications in dialysis patients]. / Kalcifikacije srcanih zalistaka kod pacijenata na kronicnoj hemodijalizi.

Chronic kidney disease (CKD) patients, especially those with end-stage renal disease (ESRD), are at much higher risk of cardiovascular disease (CVD) than the general population. High serum phosphorus (P) level play important role in pathogenesis of cardiovascular calcifications and is a frequent and important cardiovascular risk factor in patients with CKD. We aimed to investigate the association of serum levels of C-reactive protein (CRP), parathyroid hormon (PTH). calcium phosphorus product (CaxP) with cardiac valves calcifications (VC) in patients on hemodialysis (HD). We investigated for VC using colour Doppler echocardiography. VC were considered present if mitral annular calcifications and/or aortic annular calcifications were visualized. We divided patients in two groups. VC negative group (VC-) were patients with absence of VC. Patients with presence of VC were VC positive (VC+). CRP mean levels in two samples were higher in VC+ group than in VC- group (17.0 vs 3.4mg/L) and (17.1 vs 4.0 mg/L) p<0.0001. CaxP mean level in both samples was higher in VC+ group than in VC- group, 4.8 vs 4.2 (p=0.0219) and 5.0 vs 4.3 (p=0.0078). We also made analysis of absolute highest levels of three samples of CRP (CRPmax) between groups. CRPmax was higher in VC+ group than in VC- group, 19.5 vs 9.7 mg/L, (p=0.0045). We made analysis of absolute higher levels of two samples of Ca x P (CaxPmax) between groups. CaxPmax was higher in VC+ group than in VC- group, 5.2 vs 4.4 (p=0.0014). We found cardiac valve calcifications in 40 percent of patients on hemodialysis. We found that patients with correlation between PTH level, CRP level, CaxP product and cardiac valve calcifications have higher serum levels of PTH and CRP. We also found that CaxP product is higher in patients with cardiac valve calcifications. We didn't find correlation between age, dialysis duration, BMI and cardiac valve calcifications. These findings support careful monitoring of calcium metabolisum in end stage renal disease to reduce valvular cacifications and the risk of cardiovascular disease.

Sex Differences in Characteristics and Outcomes among Low-Risk Non-ST-Elevation Acute Coronary Syndrome Patients during Long Term Follow-Up.

Previous heterogenous studies show conflicting data about sex-based outcomes of non-ST-elevation acute coronary syndrome (NSTE-ACS) patients. This study evaluated 300 NSTE-ACS patients undergoing a coronary angiography between September 2012 and May 2015 that were managed with all-treatment strategies. The sample was stratified by sex and analyzed for the baseline characteristics and outcomes. The main outcome included major adverse cardiovascular and cerebrovascular events (MACCE), which were a composite of cardiac death, nonfatal myocardial infarction, ischemic stroke or urgent coronary revascularization. The female patients were older (median of 69.0 vs. 63.0 years, p = 0.008) and had lower values of BMI (median of 26.3 vs. 28.2 kg/m2, p < 0.001) and eGFR (76.44 ± 22.43 vs. 94.04 ± 27.91 mL/min, p < 0.001). There was no significant difference in the treatment strategies, angiographic characteristics and discharge therapy between the groups (p > 0.05). The female patients had significantly higher unadjusted rates of ischemic stroke (4.2% vs. 0.5%, p = 0.023), cardiac mortality (11.3%, vs. 3.9%, p = 0.022) and MACCE (33.8%, vs. 19.5%, p = 0.014); female sex was a significant predictor of MACCE in the univariate analysis (HR 1.86, 95%CI 1.12-3.09, p = 0.014); and the cumulative incidence of MACCE was higher in female patients (p = 0.014). After the adjustment, the predictive effect of female sex became non-significant (HR 1.60, 95%CI 0.94-2.73, p = 0.083), while there was no difference in the cumulative incidence of MACCE among the propensity score matched cohort (p = 0.177). Female NSTE-ACS patients have worse long-term outcomes compared to their male counterparts. However, the differences disappear after adjustment and propensity score matching. Continuing efforts and health measures are required to alleviate any sex-based differences in the NSTE-ACS population.

Gender differences in in-hospital mortality and angiographic findings of patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).

There are conflicting reports in the literature regarding the role of sex on the in-hospital mortality of patients with acute myocardial infarction. The objective of this study is to determine whether there are gender differences in in-hospital mortality and angiographic findings of patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). We conducted a prospective study of all patients admitted to University Hospital Center Split, Croatia with STEMI from 2004 to 2008 who underwent PCI. From March 2004 throughout September 2008, 488 patients with STEMI underwent PCI (364 men, 74.6%; 124 women, 25.4%). Compared with men, women were significantly older (mean age, 67.3 vs. 60.3 years; p < 0.001). Men had a significantly higher proportion of circumflex artery occlusion (19.5% vs. 10.5%, p = 0.022). A higher proportion of men had a multivessel disease than women (56.8% vs. 41.9%; p = 0.004). In-hospital mortality was significantly higher among women (11.3% vs. 4.6%; p = 0.002) but after adjustment for the baseline difference in age, the female sex was not an independent predictor of in-hospital mortality (adjusted OR 1.15; 95% CI 0.82-1.84). In men, occlusions of left anterior descending artery showed higher mortality rate than occlusions of other coronary arteries (LM 0%, LAD 7.3%, Cx 2.8%, RCA 0.7%, p = 0.03). According to our results female gender is not an independent predictor of in-hospital mortality after percutaneous coronary intervention. In men, occlusions of left anterior descending arteries are associated with higher mortality rate comparing to occlusions of other coronary arteries.

Radial artery spasm during transradial coronary procedures.

Although transradial access (TRA) for coronary procedures has many advantages over the transfemoral approach, it's still not the dominant route used in coronary interventions. Radial artery spasm (RAS) is an important limitation of TRA. We performed a search of published literature to estimate the prevalence and possible risk factors of RAS in patients undergoing transradial coronary procedure. Nineteen published papers including 7197 patients were identified as relevant; reported incidence of RAS was 14.7% altogether. It varies depending upon the criteria used, on applied premedications, and on sheath or catheter selection. Use of hydrophilic coated sheaths and catheters can reduce the incidence of RAS to 1%, while intra-arterial application of verapamil (1.25-5 mg) and nitroglycerin (100-200 µg) can reduce the incidence of RAS up to 3.8%. We concluded that RAS is still problematic in transradial access, and that besides hydrophilic materials, the use of intra-arterial vasodilators remains mandatory in RAS prevention. However, the optimal spasmolytic cocktail is yet to be confirmed by valid spasm criteria.